Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence

NCT05610761 | Completed

• 1 other identifier: Incontinence Rehab, IstanbulU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In our study, we aimed to evaluate the effects of core stabilization exercises added to traditional Kegel exercises on incontinence and quality of life in women with stress and stress dominant mixed urinary incontinence.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; incontinence rehabilitation; incontinence exercises; core stabilization exercises

Outcome Measures

Primary Outcomes (2)

• Change in Vaginal Pressure Measurement with Perineometer

  The periometer is a manometer attached to a vaginal pressure probe that evaluates pelvic floor muscle (PTC) contraction with an objective result in cmH2O. Normal vaginal pressure value is 30-60 cm H2O. The probe is advanced 3-5 cm towards the vagina and the patient is asked to contract the perineal muscles. 3 separate measurements are made and a score is created by taking the average of these measurements.

  Baseline (before intervention), immediately after intervention, 10 weeks after intervention

• Change in Incontinence Severity Index (ISI)

  ISI is a simple questionnaire consisting of questioning the frequency and amount of urine leakage, and the score consists of multiplying the answers given to these two groups of questions. Incontinence severity according to scores; mild (score 1-2), moderate (score 3-6), severe (score 8-9), and very severe (score 12).

  Baseline (before intervention), immediately after intervention, 10 weeks after intervention

Secondary Outcomes (6)

• Change in Muscle Strength Examination with Digital Palpation

  Baseline (before intervention), immediately after intervention, 10 weeks after intervention

• Change in Pad Test (24 hours)

  Baseline (before intervention), immediately after intervention, 10 weeks after intervention

• Change in Bladder Diary (3 days)

  Baseline (before intervention), immediately after intervention, 10 weeks after intervention

• Change in Incontinence Impact Questionnaire (IIQ-7)

  Baseline (before intervention), immediately after intervention, 10 weeks after intervention

• Change in Urogenital Distress Inventory (UDI-6)

  Baseline (before intervention), immediately after intervention, 10 weeks after intervention

Study Arms (2)

Core Stabilization Exercises with Kegel Exercises

EXPERIMENTAL

Behavioral: Core stabilization exercises with Kegel exercises

Kegel Exercises

ACTIVE COMPARATOR

Behavioral: Kegel exercises

Interventions

Core stabilization exercises with Kegel exercises BEHAVIORAL

Core stabilization exercise program consists of two phases: teaching the basic movement (contraction of the Transversus abdominis and other muscles with diaphragmatic breathing) and incremental exercises added to the basic movement. The basic movement will be studied before each exercise and then the specified exercises will be added. The physiatrist will teach the exercise program to the patients. The first 6 of the 12 exercises classified according to the degree of difficulty will be performed for 5 weeks, and the next 5 weeks will be moved to the other 6 exercises. The exercises will be performed at least 3 days a week, with 10 repetitions of each movement, and the program will last for 10 weeks. Compliance with the exercise program will be questioned over the phone, and patients will be evaluated with a follow-up form before the study, at the 10th week, and at the 20th week. In addition, the Kegel exercise program specified in the other group will be applied.

Core Stabilization Exercises with Kegel Exercises

Kegel exercises BEHAVIORAL

Kegel Exercises The exercise will start as 2 sets of 10 repetitions in the morning and evening, and after getting used to it, it will be increased to 3 sets of 10 repetitions per day. The patient, lying on his back with his knees bent, feet slightly apart from each other, will try to lift the breech, urinary tract opening and vagina on the pelvic floor by counting to 5, and should not tighten your abdominal and leg muscles, and should not hold your breath while doing this exercise. In this way, he will count up to 5 while contracting, then he will relax by counting to 10 (after getting used to it, the holding time will be increased to 10 seconds).

Kegel Exercises

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages of 18 - 55
• Diagnosis of stress and stress predominant mixed urinary incontinence
• Pelvic floor muscle strength ≥ 3
• BMI ≤ 35 kg/m2
• ≥ 1 complaint of urinary incontinence in the last month

You may not qualify if:

• Pregnancy and postpartum first 6 weeks
• Other types of incontinence and stress type 3 incontinence
• Urinary tract infection
• Pelvic organ prolapse advanced stage (Stage ≥ 2)
• History of pelvic surgery or pelvic tumor
• Surgical treatment for urinary incontinence
• History of serious systemic or neurological disease (Severe cardiovascular disease, advanced COPD, CVO and/or Cancer, Parkinson's etc.)
• Severe low back and/or pelvic pain

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (1)

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Merve Dikici Yağlı, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Ayşe Karan, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 9, 2022
• Study Start: July 8, 2019
• Primary Completion: March 8, 2020
• Study Completion: August 15, 2020
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

TU (1)